510(k) · Cleared
ClearedMultix Fusion Max
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · KPR System, X-Ray, Stationary
Cleared on Nov 22, 2016 as substantially equivalent to K142049 (Siemens Medical Solutions USA, Inc., 2014) after a 28-day review. Its family tree reaches back 11 generations to 1980. 10 later devices descend from it.
- Decided
- Nov 22, 2016
- Review
- 28 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K801623 (1980). 67 ancestors in all. 10 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 7 generations between
- 3 generations backK081722 YSIOSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 2 generations backK121513 Multix FusionSiemens Medical Solution · 2012 · Recalled
- 1 generation backK142049 Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc. · 2014
- This deviceK162971 Multix Fusion MaxSiemens Medical Solutions USA, Inc. · 2016
- Descendant · cites it directly · 8 of its ownK182517 MULTIX ImpactSiemens Medi Cal Solutions, Inc. · 2019
- Descendant · 2 generations on · 7 of its ownK193089 MULTIX ImpactSiemens Medical Solutions USA, Inc. · 2020
- Descendant · 3 generations on · 5 of its ownK203345 MULTIX ImpactSiemens Medical Solutions USA, Inc. · 2021
- Descendant · 3 generations on · 3 of its ownK203340 MULTIX Impact CSiemens Medical Solutions USA, Inc. · 2021
- Descendant · 4 generations on · 2 of its ownK220919 MULTIX Impact ESiemens Medical Solutions USA, Inc. · 2022
Show all 11 generations
- Root · 11 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 10 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 9 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 8 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 7 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 6 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 5 generations backK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 4 generations backK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 3 generations backK081722 YSIOSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 2 generations backK121513 Multix FusionSiemens Medical Solution · 2012 · Recalled
- 1 generation backK142049 Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc. · 2014
- This deviceK162971 Multix Fusion MaxSiemens Medical Solutions USA, Inc. · 2016
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K182517MULTIX ImpactSiemens Medi Cal Solutions, Inc. · 2019 · cites it directly8descendants
- K193089MULTIX ImpactSiemens Medical Solutions USA, Inc. · 2020 · 2 generations on7descendants
- K203345MULTIX ImpactSiemens Medical Solutions USA, Inc. · 2021 · 3 generations on5descendants
- K203340MULTIX Impact CSiemens Medical Solutions USA, Inc. · 2021 · 3 generations on3descendants
- K220919MULTIX Impact ESiemens Medical Solutions USA, Inc. · 2022 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −10 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −9 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −8 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −7 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −6 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −5 | K061054 | Axiom Aristos FX Plus | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| −4 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
| −3 | K081722 | YSIO | Siemens Medical Solutions USA, Inc. | 2008 | 11 |
| −2 | K121513 | Multix Fusion | Siemens Medical Solution | 2012 | 4 |
| −1 | K142049 | Multix Fusion VA30 & VA40 | Siemens Medical Solutions USA, Inc. | 2014 | — |
| 0 (this device) | K162971 | Multix Fusion Max | Siemens Medical Solutions USA, Inc. | 2016 | — |
| +1 | K182517 | MULTIX Impact | Siemens Medi Cal Solutions, Inc. | 2019 | — |
| +2 | K193089 | MULTIX Impact | Siemens Medical Solutions USA, Inc. | 2020 | — |
| +3 | K203345 | MULTIX Impact | Siemens Medical Solutions USA, Inc. | 2021 | — |
| +3 | K203340 | MULTIX Impact C | Siemens Medical Solutions USA, Inc. | 2021 | — |
| +4 | K220919 | MULTIX Impact E | Siemens Medical Solutions USA, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 13 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KPR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KPR device
- #1 K242119 Innovision-Exiiscore 17.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 36 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 21 of the 67 ancestors have a recall of any class.
- Of its descendants, K182517 (Siemens Medi Cal Solutions, Inc., 2019) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K142049.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · KPR
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPR
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPR
7in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPR
39in 2025
MAUDE reports naming product code KPR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 31 | 10 | 120 |
| 2008 | 15 | 48 | 10 | 95 |
| 2009 | 9 | 35 | 5 | 61 |
| 2010 | 9 | 126 | 3 | 82 |
| 2011 | 9 | 152 | 5 | 103 |
| 2012 | 11 | 58 | 1 | 74 |
| 2013 | 5 | 163 | 5 | 24 |
| 2014 | 10 | 108 | 8 | 34 |
| 2015 | 18 | 81 | 1 | 59 |
| 2016 | 11 | 84 | 4 | 18 |
| 2017 | 6 | 75 | 3 | 31 |
| 2018 | 15 | 30 | 4 | 36 |
| 2019 | 12 | 33 | 1 | 77 |
| 2020 | 16 | 39 | 1 | 41 |
| 2021 | 6 | 55 | 0 | 37 |
| 2022 | 8 | 43 | 2 | 27 |
| 2023 | 9 | 76 | 4 | 39 |
| 2024 | 11 | 162 | 1 | 34 |
| 2025 | 8 | 155 | 7 | 39 |
| 2026 | 6 | 197 | 0 | — |
What is it indicated for?
Multix Fusion Max system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion Max enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. The Multix Fusion Max system is not meant for mammography. Multix Fusion Max uses a…
Read the full statement (107 words)
Multix Fusion Max system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion Max enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. The Multix Fusion Max system is not meant for mammography.
Multix Fusion Max uses a mobile(wired), or a fixed (integrated) or wireless digital detector for generating diagnostic images by converting x-rays into image signals. The Multix Fusion Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162971 · printed Nov 4, 2026
Cite this page
510(k) Report. “K162971: Multix Fusion Max.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K162971
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026